This trial is active, not recruiting.

Summary

The purpose of the study is to determine whether vitamin D supplementation in patients with
hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with
fractures of the humerus, femur, or tibia. The central hypothesis of the study is that
vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the
risk of nonunion compared to placebo treatment.

Patients that are deficient in Vitamin D will be assigned to the randomized arm of the study. They will be randomly chosen to receive either the Vitamin D supplement or the placebo.

placebo

Patients that are Vitamin D deficient maybe randomized to the placebo group D.

Primary Outcomes

Measure

Healed fracture

time frame:
up to 15 months post-surgery

Secondary Outcomes

Measure

Nonunion

time frame:
6-15 months post-injury

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
- presence of a long bone fracture (humerus, femur, or tibia)
- age greater than or equal to 18 years
- ability to follow-up at our clinic for 12 months
Exclusion Criteria:
- pathologic fractures (i.e. occuring in the presence of abnormal bone such as a tumor,
cyst, or Paget's disease)
- open fractures (i.e. associated skin disruption) of Gustilo-Anderson type IIIB or C
(i.e. significant soft-tissue and bone devitalization)
- presence of multiple fractures
- delay in presentation for initial treatment of more than 2 weeks from the time of
injury
- preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus
with HbA1C greater than or equal to 7, peripheral vascular disease, certain
connective tissue disorders, and congenital or acquired disorders of bone metabolism)
- preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate
homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D
metabolism, parathyroid disorders, conditions causing abnormal calcium and/or
phosphate absorption)
- pregnant patients
- patients who are unable to provide consent for the study
- patients who are unable to swallow due to acuity of illness or physiologic reason
- prisoners who are patients because of their vulnerable population and inability to
follow-up

Additional Information

Official title

The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates

Principal investigator

Madhav Karunakar, MD

Description

Vitamin D plays an important role in maintaining calcium and phosphate balance in the body
and is important for maintenance of bone formation, remodeling, and healing. An extensive
literature search indicates that although there is evidence that vitamin D deficiency is
associated with fracture risk, there is no evidence of the role of vitamin D deficiency in
subsequent failure to heal. This study aims to determine whether the relationship of vitamin
D deficiency to nonunion is clinically relevant by showing whether its treatment can
decrease the risk of nonunion. We will determine the incidence of nonunion in patients with
untreated hypovitaminosis D and calculate the relative and absolute risk reductions for
nonunion with normal vitamin D levels compared to untreated hypovitaminosis D. We will also
calculate the relative and absolute risk reductions for nonunion with hypovitaminosis D
treated with vitamin D supplementation compared to placebo.

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.